How Do You Treat PTSD With Psychedelics?

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Episode 2

Brad Burge

Our guest on this episode of The Third Wave Podcast is Brad Burge; Director of Communication and Marketing at MAPS, the Multidisciplinary Association for Psychedelic Studies. Brad talks to us about his own experiences with psychedelics and how they helped him overcome bipolar disorder. Brad explains MAPS’ current work to get psychedelics approved by the FDA for various therapies, especially MDMA for the treatment of PTSD. Brad tells us what this means for the future of ‘Big Pharma’, the psychedelic movement, and our approach towards mental health.

Podcast Highlights

Brad first talks about the recent Horizons conference in New York, a gathering of researchers, psychologists and therapists interested in psychedelics. This year, around 80-90% of the delegates were there for the first time, highlighting how quickly the psychedelic movement is growing.

Brad’s own experiences with psychedelics have clearly influenced his work; being diagnosed with bipolar disorder at 11 years old, he was treated with lithium and Prozac, but discovered the healing properties of marijuana at 20. Cannabis improved his appreciation of the world, and reduced his anxiety. Realising that everything he’d been taught about drugs couldn’t be trusted, he researched other drugs and eventually tried some psilocybin mushrooms and LSD. Both experiences further enhanced his appreciation of the outdoors, but LSD was the experience that really changed his mind. The trip lasted 12-14 hours, and he says it was the first time he realised there was nothing essentially wrong our out of balance with his consciousness. He didn’t go back to his lithium prescription. It still took a lot of work for him, but LSD prompted him to exercise more, spend more time outside and drink less alcohol. Now he is free from prescription drugs and feels totally functional.

Brad clarifies that people often look at examples like his and talk about marijuana being a ‘gateway drug’. This has been disproved; people who take marijuana are no more likely to go on to take other drugs. But if people do end up using LSD or other drugs, it’s more likely that they used marijuana in the past – these are two different concepts that are often confused.

It makes little sense that marijuana, a drug similar to alcohol in its effects (although less harmful), is considered a schedule 1 drug by the DEA. Brad tells us that, historically, this was a political decision. The criminalisation of marijuana in the 1930s by Harry Anslinger was arguably the start of the drug war, and was an attempt at targeting ethnic minorities. The criminalisation of psychedelics in the 60s and 70s was an attempt by the Nixon/Reagan administrations to quash student radicalism and civil actions. These are the unfortunate facts of why the DEA schedules psychedelic drugs without basis in evidence even now.

There is still hope that the DEA will make a change; Brad tells us about their recent announcement of providing researchers with licenses to grow their own marijuana for research. Previously, all researchers had to obtain their marijuana from a government owned farm in Mississippi. Now, the monopoly of the federal government on marijuana production that has been limiting research may be lifted. All that needs to happen then is for the FDA to approve marijuana for medical use; then the DEA would have no choice but to remove it from the Schedule 1 list.

Considering that in the 60s and 70s, the DEA approved prescription drugs that did not have solid scientific evidence, it appears that the DEA do not ground their decisions entirely in the research (For more see “Anatomy of an Epidemic” by Robert Whittaker.) Brad tells us that although the DEA make poor decisions, the FDA have been very supportive of psychedelic research. The FDA genuinely do want to develop drugs that work, not just drugs that benefit Big Pharma by requiring frequent prescriptions with minimal benefits.

If things go as they are, the FDA are set to be very supportive in MAPS’ aim to get MDMA approved for therapy by 2021. If that happens, Brad tells us to expect Big Pharma to be unhappy; not only would they struggle to patent drugs like MDMA or psilocybin, but drugs that work through one or two doses a year are not profitable at all. Big Pharma has a lot of lobbying money, and they will use it to keep pushing against psychedelic therapy. Their main objective will be to convince people that they are broken, and need constant chemical intervention to fix them; that way, they can keep selling their ineffective, expensive drugs.

MAPS is currently spearheading a new form of capitalism called the ‘Benefit Corporation’, which allows a company to do social good while still generating an income. Other examples of these benefit corporations are Mozilla and Patagonia. In the case of MAPS, once MDMA is approved for therapy, income can be donated from their benefit corporation back to the non-profit part of the business, allowing more research and less time asking for donations!

Brad tells us that psychedelic therapy will be a paradigm shift in the way we view mental illness. It does not have to be about taking a drug for every day for the rest of your life, feeling like there is something permanently wrong with you. MAPS’s proposed therapies will be humanistic, and not determined by profit. MAPS also hopes that medicalization of psychedelics will lead to a legalization of psychedelics, as we’ve seen with marijuana. MAPS believes that psychedelics can be used for spiritual growth and creative purposes – even for fun, when used responsibly. Rick Doblin, the founder of MAPS, has mentioned the idea of having ‘licenses’ for psychedelic use. Just like how you have to pass a test to drive a car, you would need to prove your responsibility with the use of psychedelics. Break the rules, and you lose your license.

Finally, Brad talks to us about his opinion on the use of psychedelics in the entrepreneurial world. More and more, creative business people are using psychedelics to provide them a boost in their work. Brad thinks this is a powerful part of the psychedelic movement, because rather than a Timothy Leary ‘Turn on, tune in, drop out’ attitude, it’s a ‘Get better at what you’re doing!’ attitude, which is naturally less counter-cultural. Microdosing in a business sense, however, will naturally bleed through to affect people’s spiritual wellbeing. Brad points out how much capitalism relies on how people are feeling – especially in the stock market – so psychedelic use in the business world could really end up making a big difference.

Brad believes, however, that the fastest way towards psychedelic legalization is through approving MDMA therapy. To do that, MAPS needs to raise $13-14million in the next five years. Entrepreneurs, enthusiasts and sufferers need to all come forward and talk openly about psychedelics to help reduce the stigma!

Podcast Transcript

00:00 Paul Austin: Welcome to the Psychedelia Podcast, where we talk about the third wave of psychedelics. Through our many wide-ranging conversations with scientists, policy-makers, entrepreneurs and event organizers, we bring you an exclusive look into the many minds of the psychedelic world. It's time to let the word out about psychedelics, and how they can be used as tools to benefit both the individual and the community. Welcome to Third Wave.

00:30 Paul Austin: Hey, listeners, and welcome back to The Third Wave Podcast. We have another special guest for you today on the podcast. His name is Brad Burge, and he is the Director of Communications and Marketing at MAPS, the Multidisciplinary Association for Psychedelic Studies. And Brad is on the podcast today to talk to us about his experience with psychedelics, what role that played in helping his professional pursuits and career at MAPS, and then what he perceives as head of marketing at maps for the next five to 10 years of psychedelics. So, Brad, thanks so much for joining us.

01:06 Brad Burge: Thanks so much for having me on, Paul. It's really an honor to be on.

01:12 PA: It's great to have you. Now we met at Horizons about a month ago, is that right?

01:17 BB: Yeah. Yeah, yeah, yeah, time flies, the Horizons Psychedelic Conference in New York City. That was really quite an event.

01:24 PA: Yeah, and so, what brought you to Horizons? Why were you there?

01:29 BB: Well, yeah, Horizons is an annual conference that a group of researchers, psychologists, therapists puts on in New York City. And I hadn't been to a Horizons Conference since 2010. So 2016 to 2010, I've been working with MAPS throughout that time, just to see how the field has changed and to see how the composition of the people has changed, was just really amazing. I've heard a lot about the excitement coming from the Horizons Conference from my colleagues, from researchers in the field of psychedelic science and medicine. And so I just really wanted to take the opportunity to go out and see what happened. And since 2010, the size of the conference has just ballooned. I think there were about 200 or 250 people there in 2010, most of whom were kind of insiders in the field of psychedelic research, people who have been working to either restore psychedelic research back to legitimacy for decades, or people who had been therapists who really used psychedelics in therapy before they were criminalized.

02:37 BB: And then this year, it was just amazing. One of the hosts for the Horizons Conference asked people in the very first session, "How many people is this your first Horizons Conference?" And 80% of the room, 80% to 90% of the room raised their hands. And that's just... I mean, that speaks... For me, it spoke of how the field is growing and how much interest there is from especially young people in finding a place in the field.

03:04 PA: Yeah, and I think it's really interesting that you bring this increase in popularity up because I noticed that as well, and I thought, "Why is this going on? What's happening?", and of course, that's why I'm so happy to be talking to do 'cause I really wanna get into that later on in this conversation. But before we quite get to the meat of it, tell our audience a little bit about your psychedelic experience. So, why are you even working at MAPS? Why were you at Horizons? What was your introduction to the psychedelic experience?

03:36 BB: Yeah, so good question. First of all, I'll just say that really is kind of the meat of it, in a sense, at least for me. I know there's a common perception that everybody who's involved with MAPS or with psychedelic research or psychedelic therapy has in some way experienced psychedelics for themselves. In my case, that is true. But in a lot of cases, it's not true. It's often people who have been affected by post-traumatic stress disorder, or people who know people who have been affected by PTSD, or people who know people who had difficult psychedelic experiences, or even people who are just curious and they've heard about it. So, I'll just say everybody has in some way, been touched by psychedelics in some way but hasn't necessarily used them who's involved in this field or by areas where they could possibly be of help.

04:26 BB: So, yeah, a lot of people, especially younger people who come to MAPS and they write to us and who express an interest in what MAPS is doing, have come to thinking about psychedelics because they've experienced them in a more or less a recreational context, people who are in high school or in college who are experimenting with alcohol and other drugs including psychedelics. People who come across these psychedelics are often coming across them in a party context. That definitely wasn't my experience. I wasn't going to raves, I didn't go to parties and use psychedelics with people. I first found psychedelics in college. I had a couple of early pretty mellow experiences with mushrooms. I definitely had started using cannabis before then, but only when I was about 20. I think a lot of people are starting to use cannabis when they're 13, 14 years old now.

05:23 BB: But it wasn't even my first experience with drugs. My first experience with drugs was actually, I was much younger. I had been on prescription mood stabilizers, lithium in particular, also antidepressants like Paxil and Prozac since I was about 11 years old. I was diagnosed with bipolar disorder. I had a lot of intense feelings of just anger and frustration when I was young. I didn't wanna go to school. I'd lash out and be angry. And my family was searching for a solution, not knowing what to do. It can be hard, in retrospect, I know, just dealing with kids and especially kids in an increasingly mediated environment. I think I really need to get out more, being surrounded by televisions and video games and just the social difficulties of dealing with the public school system, all of these things combined just made it difficult for me. Of course, family dynamics, growing up, also difficult.

06:19 BB: So, my experience was just of being a kid and trying to cope in an uncertain world. And as part of that process, I was put on these mood stabilizers, and I was on those, lithium in particular, until I was 20 years old, until I started using marijuana in college. I just decided to start trying it 'cause people around me were using it, and I heard it was useful, and I heard it could be a better alternative to alcohol. I was kinda tired of the hangovers, I was tired of the alcoholism that was rampant at my school, at Stanford, it was class of 2005. And I think alcoholism is probably a much larger problem on college campuses than psychedelics will ever be. So I was searching for alternatives to alcohol and found marijuana. And it was my first experience of using a drug and actually having a genuinely pleasant connected experience. I kind of slowed down, I started appreciating nature. I'd always appreciated nature, I was raised to go camping and hiking, but cannabis really enhanced my appreciation of nature and that kinda helped me slow down and not be so anxious about school, and not be so anxious about social situations.

07:26 BB: And so that kind of prompted my thinking, like, "Which drug would I prefer to be using to manage my... What I experience as my mood swings?" And so, cannabis seemed to help with that. I kept taking the lithium, though, because I had a regular appointment with a psychiatrist, I'd been taking the drugs for a long time, and I still really believe that I needed some kind of a pharmaceutical supplement in order to keep my moods balanced and to make me a functional human being. It is kind of an internalization of these many years, is over a decade of going to psychiatrists, therapists, and learning that something was sort of essentially wrong with my chemistry. So, having tried cannabis, I was like, "Well, the war on drugs... " I've always been like, "Don't use drugs, and be careful," and I heard all these horror stories about them, and having tried cannabis and found, "Oh, this is actually quite clearly, in my experience, less harmful than alcohol. What can I trust about everything else that I've heard?"

08:23 BB: So I started doing my research, I looked at the history of psychedelics, I read about... I read Alan Watts, I looked at all of Timothy Leary's books, I looked at the chemistry and pharmacology of them, everything I could learn about them, before finally trying a little bit of mushrooms in a milkshake and taking a walk around the Stanford campus after dark, and just being amazed by how beautiful the street lights looked and how trees took on this special sort of ethereal quality, and further enhancing my appreciation for the outdoors and sensory experience in general. And I kind of accidentally stumbled upon LSD. And LSD, to be honest, was really what changed my mind. I took two tabs of LSD and clearly fairly good stuff, because I had a very long experience, 12 to 14 hours. I took the entire time, I spent a little part of it with a buddy of mine, and we sat on a log and watched a snake crawl over a rock and spent the rest of the time walking in a loop. I walked about 10 or 20 times around the lake on the Stanford campus, which is this little man-made lake, it's probably about a half a mile or three quarters of a mile long.

09:35 BB: So I did quite a bit of walking that day, and during that time, I just absorbed the beauty of the nature around me, it was a big, beautiful, bright sunny day with bright clouds and the sort of apex of that experience for me, it wasn't feeling separated from my body, it wasn't this sort of profound, cosmic experience of connectedness. It was pretty... At the time, it felt pretty mundane, I just kinda looked up at the sun and realized how much I was appreciating it and how much I was enjoying myself in my time and feeling so just at peace and calm during my time outside that day. And it was really the first time I think I realized that there was nothing essentially wrong with my consciousness, that there was nothing out of balance or strange about it or something that I had to medicate in order to be a functional human being.

10:28 BB: So the next day, I called my psychiatrist and said, "We're done," and I didn't go in for another appointment, I didn't refill my prescription, and I stopped taking my mood stabilizers at that moment. And now I'm not saying it was an instantaneous cure for bipolar disorder, or that anybody diagnosed with bipolar disorder should necessarily use it. It's different for everybody, because it also took a lot of work after that. It wasn't that I just went off my drugs; I also realized that I needed to spend more time outside. I needed to do more things that actually genuinely made me feel happy rather than taking the classes or pursuing the job or behaving or acting in the way that people around me thought that I should. So, I started getting more exercise, I started drinking less alcohol, I continued using marijuana. And then as medical marijuana laws just have gotten stronger, I've been using medical marijuana since then, and I'm a totally functional human being, and I'm off of my prescription drugs. So, as a result of those experiences throughout my later education, after I was done with undergraduate school, I did some traveling and then I went to grad school, I wanted to focus my intellectual pursuits and my energy on finding out what this medicalization of marijuana and the medicalization of psychedelics could possibly do for people.

11:43 BB: And that's how I eventually found MAPS. I just did some research, I wanted to do a doctoral dissertation focused on MAPS and learn so much about the movement to restore psychedelic research, and what Rick Doblin and MAPS have been doing since 1986. I decided to leave my graduate program, I took my Master's and ran and just decided to find a place in the drug policy advocacy community and eventually started working with MAPS.

12:11 PA: Interesting, very, very interesting. Now I have a question about... You went through this experience with marijuana, leading to mushrooms, leading to LSD. It sounds like it was a progression there, which, I went through a very similar thing myself when I was 16. I smoked marijuana for the first time. The context was slightly different, but I was still drawn to that for certain reasons. And then after that, it was LSD when I was 19, and so on and so forth. And so it seems like this is a fairly, for more and more people who are becoming interested in psychedelics, it tends to be that progression. Why do you think that is? Why is it marijuana that people often first become introduced to as, we could say, a plant medicine or it's something that they feel may be subconsciously drawn to, or as a substitute for alcohol, like it was for you? And then how does that act as an instigator for maybe an introduction to psychedelics?

13:09 BB: Yeah, the question is, where is this gateway theory coming from, right? Scientifically, the gateway theory has been completely disproven, that marijuana use does not necessarily lead to later use. But if you do end up using LSD or other drugs, you are more likely to have used marijuana. And that's a very, very different statement. So people who are naturally inclined to certain drug experiences are more likely to use marijuana than people who are not. So that's what the actual... That's what's actually happening. People are being moved from marijuana to another drug. They're just already moving in that direction and of course, they use marijuana, because it's one of the more widely available. Marijuana is... It has fairly subtle effects compared to psychedelic drugs that has psychoactive effects comparable in their intensity to alcohol.

14:03 BB: So you can be social, you can obviously use too much marijuana, just like you can use too much alcohol. So, I think it's comparable in that way. And also, it's a naturally occurring plant, so I think for a lot of people, that's just more accessible and people are more likely to flex the law or become medical marijuana patients and try marijuana than they are to use synthetic compounds. I think there's also a lot more fear-based propaganda and decades of really negative, biased research surrounding psychedelics than there has been for marijuana. LSD is... It has a lot of fear associated with it. In our culture, it's the quintessential drug of the so-called psychedelic counter-culture of the 1960s and acquired that meaning. And there's also such a lack of education surrounding LSD and psilocybin or magic mushrooms. People often equate LSD and heroin, but equating LSD and heroin is a lot... It's like equating aspirin and marijuana. They're just completely...

15:09 PA: Well, it's ridiculous, is what it is, yeah.

15:12 BB: Right. And the only reason we conflate them is because they're on the same list of Schedule One drugs. And they've been part of the same drug war propaganda for the last 40 years.

15:23 PA: And why is that, why is... Obviously, and this is something I joke about, not joke about necessarily, but more talk about seriously with friends, that the DEA just came out a month or so, maybe two months ago, saying they weren't going to reschedule cannabis as a substance, even though 25 states have now passed medical marijuana laws. And just for those who are listening, a Schedule One substance is a substance that is highly addictive and that has no medicinal value. And this is according to, I believe, the FDA or the DEA?

15:56 BB: The schedules are determined by the the DEA, the Drug Enforcement Administration, which is a law enforcement organization. And they have historically been, shall we say, flexible with their interpretation of scientific evidence. So, that's one of the major things that researchers are working on now, is trying to develop the evidence about psychedelics and cannabis such that the DEA will be forced to move these substances out of Schedule One.

16:27 PA: And so why is it still, even though there has been a lot of research done in cannabis, even though 25 states have legalized medical marijuana for use, and even though clearly through the research that was done in the '60s, for example, on psychedelics, there were certain benefits shown that were... That clearly differentiated it from substances like heroin. Why is it that some of these substances that we know and understand to be facilitators of healing are still Schedule One substances?

16:56 BB: Yeah. Well, yeah. Looking back at the history, it was a political decision. In the 1960s and early 1970s, when there was a strong environment of political change, there was a lot of, especially, student radicalism, civil rights. There were large groups of students, young people, minority groups, who were yelling at that time very, very loudly for greater rights for the end of the Vietnam War, for voting rights, for the end of Jim Crow segregation. There was a whole lot going on that the powers that be at the time, especially the Nixon administration, Reagan administration, that the administrators at the time at the federal level, especially, didn't want happening. And so, the war on drugs, the criminalization of psychedelics in particular, was a very explicit, very intentional, even now public with the admission of some former Nixon administration officials who have publicly stated that the criminalization of psychedelics and cannabis in the 1960s and 1970s was specifically intended to target specific student radical groups and groups of ethnic minorities who are using those substances.

18:18 BB: So it was a way to arrest, to incarcerate, and to prevent any sort of civil actions from taking place. So it was a very political decision at that time. Marijuana, of course, has been criminalized since the 1930s. And very similarly with Anslinger, who was the drug war sort of the initiator of the drug war in the United States, was using the criminalization of cannabis to target also ethnic minorities at that time. So, it's been a long history of racial targeting and the elimination of civil justice movements that's made the drug war so entrenched. And I think we're finally starting to see some big changes. So I think it's not all dark news, I think people are starting to shift their opinions at a lot of levels about the drug war.

19:06 PA: And I think you're right, and I think that's important to emphasize, that in a world where we're constantly bombarded with pessimistic messages, not only specific to drugs and substances, but also the mass media in general tends to do that. We're dealing... We're five days away as we record this interview from an election where we have two candidates that people aren't too happy about, we could say. So, it is important to emphasize that there is an optimistic perspective, but it still blows my mind in 2016 with the amount of information that we have available to us, with the fact that California will likely legalize marijuana in five or six days or at least start the process of legalization, that you still have a DEA that has said that marijuana has no legal value, that it's still a Schedule One substance. And even things psilocybin and LSD... It's ridiculous. And MDMA as well is on Schedule One, if I believe, or if I'm correct.

20:02 BB: Yeah, it sure is. And I'm glad you brought up the DEA statement again, because it is true that the DEA sent out a statement saying that they were not going to reschedule marijuana at this time. However, what was far less covered was literally the second paragraph in that news release from the DEA, or maybe it was even the first, but in any case, the media only it chose to cover half of that release. The other half of that was the DEA announced that they would be allowing, they would be granting additional licenses for researchers that wanted to grow marijuana for marijuana research.

20:41 PA: And why does that matter?

20:42 BB: That matters because... So the DEA, as a drug enforcement organization, it is not there to change laws. It sees its position and its mandate, is not to change laws; it is to enforce laws. So, the DEA is, at least ostensibly, because we haven't seen it yet, ostensibly responsive to clinical trials that have been completed with approval from the FDA. So, if the Food and Drug Administration, another federal agency, were to approve a particular Schedule One drug for a medical use, that would disqualify it from Schedule One, and the DEA would be forced to remove it. Now this has never happened before, it hasn't happened yet, that the FDA has approved a Schedule One drug. There's a lot of movements towards that now with MDMA, marijuana and psilocybin. But should the FDA approve one of these substances for therapeutic use, the DEA would be forced to reschedule.

21:42 BB: So, up until now, since the 1960s, there has been one provider of marijuana for research in the United States, and that's a farm at the University of Mississippi run by the National Institute on Drug Abuse. That monopoly held by the federal government on the availability of marijuana for research in the United States that has prevented research from taking place that could have been happening already to develop marijuana into an FDA-approved prescription drug. So, researchers are held back by this monopoly, and these researchers include MAPS, MAPS has been working to get research to develop marijuana into a prescription treatment for PTSD for about seven years, and we're just about to start the study now. So, by announcing that they are going to grant these additional licenses, the DEA is opening up the possibility that researchers could develop marijuana through the FDA process into a prescription drug. So, at the same time as they're saying, "No, we are not going to reschedule it," saying that there's not sufficient evidence, they're also opening up the possibility of generating more evidence.

22:49 PA: And so...

22:50 BB: So they're kind of like, "We can't make these changes, but we're willing to allow you to try to convince us." So that's a pretty significant step.

23:00 PA: And are you hopeful? I know MAPS has... They've scheduled for 2021, hopefully, to complete phase three of MDMA trials for PTSD. I know that with work that Roland Griffiths is doing at Johns Hopkins in psilocybin, there's also so many interesting things going on there. My second question is a follow-up, then, is... In this... I read a really interesting book a few months ago that was recommended by a friend called Anatomy of an Epidemic by Robert Whitaker, which is basically about the over-prescription of antidepressants and anti-psychotics and anti-anxiety pills and how... Yeah, we could call that the general feel of it. There's a lot more to that book as well, but one point specific to what you're talking about is that in the '70s and '80s, the FDA approved certain substances for depression and for some of these other mental health systems that, looking back at the research and even the research at the time, it should not have been approved because it wasn't sound research and it was clearly shown that they were not effective the way the drug companies, big pharmaceutical companies wanted it to be effective.

24:10 PA: And so, my question would be, with that understanding that maybe it's not just science and research only, is there any type of questions about the role, for example, most people say, you might hear some people say that, "We live in an oligarchy today," that corporatism and that big pharma and that big oil and that other big companies, they run the federal government and dictate certain policies of the federal government. And so, my question would be, is there hope within the psychedelic research space specific to what MAPS is doing, that when this research comes out, that the FDA will actually cooperate even though it's going to cut into the massive profits of the pharmaceutical industries that lobby at the federal level for Congress?

25:00 BB: So part of the question is, to what extent are the FDA and the corporate oligarchy in collusion...

25:07 PA: We could say that, yeah.

25:09 BB: We've had a great relation, that is, MAPS and other researchers have had a great relationship with the FDA since the mid-'90s. The FDA has been very supportive of our protocol developments, they've approved all of our trials of MDMA-assisted psychotherapy for PTSD and other psychedelic clinical trials in the US, and have been very responsive. In fact, coming up right this month, November 29th, we are sending some of our clinical research team to FDA headquarters in Maryland to have a 90-minute meeting with the FDA, a meeting which takes six months to plan for, to come to an agreement on the design of the next phase of research, the phase three clinical trials. So, we've been advised by our retired senior FDA consultants, former senior FDA officials who used to work in the division of psychiatry products at the FDA, that we should, in addition to submitting this proposal for our phase three clinical trials, also request what's called Breakthrough Therapy Designation.

26:13 BB: And that's a special designation within the FDA drug development process that gives that research special attention from the FDA. It can accelerate the approvals process, and it can get you more access to senior regulators at the FDA, so the FDA can really consult with us on the progress of the trial, and that can maybe we can treat fewer participants, making the trials less expensive and positively take less time. So we're hoping right now that we get FDA approval for MDMA-assisted psychotherapy for PTSD in 2021. This breakthrough therapy doesn't - actually it could accelerate that by a year or more. So, we have a lot of encouragement from the FDA and then also from our retired FDA consultants that... We have a lot of support from the FDA, in other words. So, I think as to your question, as to the role of where the for-profit pharmaceutical industry comes into this, the FDA really does want to see the development of drugs that work, and drugs with research, with strong effect sizes.

27:26 BB: So we're actually seeing that not only is there a statistically significant change that we see in this population, but that also that change is actually relevant. So a lot of the currently approved drugs... So the two currently approved drugs for PTSD are both SSRIs, they are Zoloft and Prozac. And currently, that's what people are taking for PTSD symptoms, and people have to take them every day, multiple times a day, sometimes for months or years or the rest of their life, and still they don't see any long-term improvement, so they're still taking these drugs regularly. And so, nevertheless, the effect size, so actually, the amount they're improving, if you look at the clinical trials that got those drugs approved is actually very, very small. They might just be improving just a slight bit, but they're still taking these drugs and they're still getting all the side effects from those drugs.

28:21 BB: The difference with MDMA-assisted psychotherapy and generally the model for psychedelic therapy is that people only take the drugs two or three times over the course of a couple of months. So it's a totally different model. And then also, in the phase two clinical trials, we saw effect sizes that were way bigger than the effect sizes that were approved for... Are currently approved treatments for PTSD that are pharmaceuticals. So, I think the FDA is enthusiastic that this could actually... We'll see after this phase three meeting to what extent the FDA is excited that this really does represent a breakthrough treatment. And something like that could, I think, radically change how we look at mental healthcare and hopefully could provide a really useful and far less expensive alternative for people for dealing with PTSD.

29:12 PA: Absolutely. And I think this is a really nice segue into the next question that I wanted to ask or even the next kind of part of this conversation that I wanted to get into, is I would anticipate that as some of these substance become medicalized for use for things like depression and for things like obviously PTSD, for potentially anxiety, for bipolar, there will be some pushback from big pharma because it will significantly affect their profit shares and and their profit values.

29:46 BB: Yeah. Yeah, yeah. That pushback... We'll see. The pharmaceutical industry has a strong lobby, so they spend a lot of money on political lobbying so that could come into play. At this point, I can only hope it comes into play because it means that we're winning. But as far as their ability to compete, what does the for-profit pharmaceutical industry have? Their main incentive is to generate profit for themselves and for their investors. Their main incentive is not to provide a public benefit. So, MAPS's development of these drugs, it's not only a nonprofit effort in the sense that we're not trying to develop the drugs that are gonna make us the most money in the long term; we're trying to develop the drugs that most directly address significant social issues. That's why we have a 501c3 nonprofit status because the IRS says, "Yes, that's a significant social issue." So, yeah. So, MAPS has also spearheaded this really, really interesting new form of capitalism, in a sense, called the benefit corporation. So, a benefit corporation is a new kind of legal corporation that's only been around for the last several years, maybe five or 10 years, and there's only a handful of them. There's more and more that is...

31:03 PA: Patagonia, I know, is a benefit corp.

31:05 BB: Yeah.

31:06 PA: That's probably the most well known benefit corp.

31:07 BB: Patagonia, yeah.

31:08 PA: Patagonia is one. Etsy, I think, is another one.

31:12 BB: Yeah, Mozilla also?

31:14 PA: Mozilla is... Okay, yeah, yeah, yeah.

31:15 BB: Yeah, yeah. The Firefox browser?

31:18 PA: Mm-hmm.

31:18 BB: Yeah. So, yeah, really interesting, really interesting. It's a way to allow for the development of products and services that can serve a social good, but then also generate an income for the organization that's developing them. So, in the case of, say, in the case of psychedelic therapy, MAPS at the beginning of last year, we started a benefit corporation. So, Multidisciplinary Association for Psychedelic Studies or MAPS, that's the 501c3 nonprofit, that's the one that I work for. We also have a wholly-owned for-profit subsidiary called the MAPS Public Benefit Corporation. And so, what the purpose of that is is so that once MDMA is approved by the FDA, the MAPS Public Benefit Corporation will be able to market and sell MDMA, charging slightly higher than it cost us to make it, and then also train therapists in how to administer MDMA-assisted psychotherapy and get an income from that. So that could be tens of millions of dollars over the first several years, depending on how quickly we can roll out the treatment. And that money will then be donated back from the public benefit corporation back to MAPS than on profit.

32:34 BB: And so, all of a sudden, once MDMA is approved, MAPS can have an independent income stream which then goes back to funding further research into MDMA and LSD and to all other sorts of things. We'll be able to start microdosing research, we'll be able to just do a lot more, and we won't have to spend so much time asking for donations. So, there's a sense in which donations now to help us complete that research can actually make MAPS a sustainable, nonprofit organization for the foreseeable future.

33:02 PA: And that's excellent, and that's fantastic. And so, the follow-up question for me, then, and we spoke, I'd mentioned this to you before we actually have done the call, but we're seeing a lot of commonalities and similarities with marijuana and what's happened with the medicalization of marijuana and now the legalization of marijuana and potentially, what's happening with psychedelics. So, I'll kinda do a brief history. California legalized medical marijuana in 1996, I believe, so the big question, then, after that and what I wanted to follow up on, we spoke about this before we hopped on this call as well as with what's going on with marijuana and what has happened with marijuana, California legalizing medical marijuana in 1996, and now 20 years later, there are 25 states that have legalized medical marijuana, including four more with this upcoming election that might legalize medical marijuana.

33:53 PA: And also, obviously, four states plus the District of Columbia have legalized recreational marijuana, and there are five more states who are voting on that in this upcoming election, so it's... So we're seeing this progression where because of medicalization of a substance like marijuana, it has helped to actually strip away the stigma that society attaches to it and opened the doors for full-on legalization. Now some issues that we're seeing because of that which ties into what you just spoke about with MAPS and the Public Benefit Corporation is with the marijuana industry, a lot of people are concerned about big green, so to say. So it's looking like within a few years, marijuana could be a $22 billion industry, and so a lot of people are worried that we might have to deal with corporate interests in marijuana as well. What do you think will happen with the medicalization of psychedelics that will potentially prevent any type of corporate private first interest from, so to say, patenting a certain type of psychedelic or an analog of a psychedelic and then selling it in such a way where they can maximize, we could say, profit share for private investors?

35:05 BB: Yeah. Well, first of all, all the psychedelics that we're talking about right now about developing are either out of patent or can't be patented.

35:13 PA: Okay.

35:14 BB: So MDMA was first synthesized in 1912 by the Merck Pharmaceutical Company. They didn't use it for anything, they didn't even do any experiments on it, so that's way out of patent. So, MDMA, the molecule, will be a generic drug, so, anybody with a license to manufacture generic prescription drugs will be able to make it and distribute it. So, same with LSD. LSD is long out of patent, although that research is significantly farther behind than the MDMA research, and psilocybin, that's of course, a naturally-occurring compound found in a mushroom, that also can't be patented. You can patent certain isolation pathways, so certain ways of isolating it or synthesizing it, but as far as psilocybin, the molecule itself, one psilocybin molecule is the same as another psilocybin molecule, so that'll be a generic drug.

36:02 BB: And marijuana, same, that's a plant, you'll be able to patent and you can now patent certain delivery systems, certain isolates, certain ways of isolating THC or CBD, for example, but you can't patent the marijuana plant. So, there will always be sufficient competition in the generic marketplace to make sure that there is no one single company that can make a significant profit off of any of those. Now, as far as different analogs, analogs will remain illegal until they're approved, until they're developed through an FDA drug development process. So you couldn't just make a new psychedelic and start selling it to people. That would still be illegal. Yeah.

36:43 PA: And that's a fantastic question, and I wanted to ask you that question specifically because I was having a conversation with someone last night at dinner, and she asked me that, and she's like, "Is there concern that with the eventual medicalization of psychedelics and potentially legalization, that you still might have for-profit companies or industries that take advantage of that and significantly spike prices?" And some people say just off-hand, "Oh, this will still happen." I think that's because they largely perceive life, or not life, they perceive that what's going on right now will continue to happen in the future, whereas I think we're seeing a number of structural changes that's starting to change the way that business is done. One of those is the B Corp that you mentioned.

37:28 BB: Yeah, yeah, and hopefully, psychedelic therapy represents that kind of a paradigm shift, too, for medicine, that once we have MDMA-assisted psychotherapy for PTSD approved, people will realize that treating mental illness does not have to be about taking a drug every day for the rest of your life.

37:43 PA: Right.

37:43 BB: It does not have to be about having something essentially wrong with your functioning, and then all the internalized identity that happens as a result of that that, that we can just address things at their root with a more humanistic approach to treating mental illness. So that could change things, too. And if that's the case, then the for-profit pharmaceutical industry's only possible response to that would be to market their own drugs more heavily and try to continue convincing people that they're broken and that they need to take these specific drugs in order to be functioning human beings. And I think our culture, especially young people right now, are getting kind of less and less convinced by that.

38:27 PA: And I think that's a really, really important topic, or an interesting topic, even, to discuss because as we've been speaking about on much of this interview, we've been talking about research and the medicalization of psychedelics, but clearly, it's not only the research that matters. That plays really, really important part, but we're also looking at larger cultural changes that are opening the door for eventual marijuana legalization. What do you see outside of only the research that's going on which will significantly help with the medicalization of psychedelics, what do you see happening potentially in the next five to 10 to 20 years in terms of cultural changes that will help to open the door for full-blown legalization of psychedelic substances?

39:11 BB: Yeah. There's been a lot less discussion of legalization of psychedelics than there has been for the legalization of marijuana. And I think that's partly because there's just fewer people who have had experiences with psychedelics compared to people with marijuana. I don't know the numbers, but certainly, millions of people have used marijuana and have those experiences in the US alone, and I don't... Maybe the number is a million for psychedelic experiences. I think it's higher.

39:38 PA: I think it's like... I think for psychedelics, it's about 10%, so it's specific to the United States. In 2000, recently, they came out with a survey that said about 10%, so about 30 million, which is still a significant amount but not near as many as marijuana, obviously.

39:56 BB: Not nearly as many as marijuana, definitely. That's still a lot of people, though.

39:58 PA: Yeah, yeah.

40:00 BB: For sure. And probably most of those people are just one or two experiences. They're not regular users, and they're not people who are likely to just drop everything and go to a rally to go legalize psychedelics.

40:10 PA: Correct.

40:10 BB: Most people. And also, there's also the demonizing aspect, is that LSD and the psychedelics are just more demonized than cannabis is. It just seems to have always been the case since they came about. So, there's this less direct lobbying or political movement around that. Psychedelics were just discussed just a couple of months ago at the UN, the United Nations General Assembly special session on drugs or the World Drug Problem, as the title was, where representatives from all over the world came together to talk about better approaches to war on drugs, especially as it effects Latin America and third world countries and more impoverished areas of the world. And so, there's more and more conversation about that, although there were no concrete steps taken at the UN this year to actually make some big proclamatory statements about that. But it's certainly becoming a matter of conversation.

41:07 BB: And as far as the next 10 or 20 years, we definitely hope that the medicalization of psychedelics brings it back to a place of rational conversation rather than just throwing them all out the window, throwing out the baby with a bath water, and just saying, "Hey, we just shouldn't even look at these things." Changing that conversation in the media, at universities and colleges, at conferences, in the political sphere. As that conversation becomes more, I'd say, responsible, that we're not just responding with fear to psychedelics and we're looking at them from a scientific lens as we start to learn more about what they're actually doing in the brain, then it'll become more possible to talk about what a possible future legalization of psychedelics might look like. And there's been some thinking about that. We at MAPS hope that eventually, people will be able to... That adults will be able to legally use psychedelics on their own, not just for treat mental illness, but for spiritual growth. There's already a certain number of religious movements using ayahuasca and peyote in particular, that they actually have permission in the US to use psychedelics in their spiritual practices for members of their church.

42:18 BB: So there's movement in the religious domain as well. And we do hope that also, the people are just able to use them for creative purposes, like microdosing or even macro-dosing for a creative purposes, and then also just for fun. They're... Given that psychedelics really don't have nearly the level of harms that they've been broadcast as having for the last 40 years, and given that they really do have some or a whole lot of beneficial uses when used carefully in the right ways, with the right intention, in the right settings, given that, we do want people to be able to have access to the one way that's been thought about by Rick Doblin, the founder of MAPS, who's been the visionary for what this future might look like, is that maybe we treat them like driver's licenses. Psychedelics and cars have a lot in common in the fact that not only are they the transportation devices but they're also both used for potentially very useful purposes and also can be very dangerous when used by the wrong people in the right ways, in the wrong state of mind for the wrong reasons.

43:27 BB: And so just like we give driver's licenses to people and you have to take a test and you have to be evaluated and say, "Yes, I understand these risks, and yes, I'll follow these guidelines. No, I won't hurt anybody," and all of that, and then we give licenses and then people can go on buy psychedelics and use them in either particular spaces or in private spaces. And if they misuse them, or they sell them to people who shouldn't have them, then you revoke licenses, just like we do with driver's licenses. So, that's just one way of thinking about how that might be regulated in the future, keeping in mind, really, that marijuana legalization and psychedelic legalization don't need to be the same thing, that the war on drugs has arbitrarily, and for political reasons, lumped all of these drugs together into a particular category, which leads people to think that they all have some similarity as far as their risks and their effects when really, they don't. So I think that... Yeah, I think we're seeing some pretty significant movement, culturally, recasting how we're thinking about them. And yeah, I think that's really promising. I think the next 10 years, we're probably not gonna see any big legalization for psychedelics, but I think we are gonna see the conversation shift significantly. And who knows, that could change, time seems to be accelerating.

44:40 PA: It does, with the advent of the Internet, it seems like aggressive movements have exponentially grown and... But at the same time, things seem to be becoming more extreme, to some degree. Whereas you have these people who are still are holding on to these values that are based on fear and xenophobia are holding tighter and tighter to those. Whereas the general public seems to be moving to a point of more love, more acceptance, less divisiveness, and I think the Internet helps to facilitate that change and that even exponential change and what we're seeing with substances and psychedelics and...

45:17 BB: Yeah, yeah. If we can just look at all of these things as tools that we can either use beneficially or we can use poorly, then the conversation opens up a lot.

45:25 PA: It does. It does, it does, absolutely. So, great. So, one last question for you before we wrap up. Part of what we're trying to do at Third Wave, part of what we're focusing on Third Wave, is changing that cultural conversation and we... I was having a conversation with a close friend of mine four or five months ago, and I was telling her about this new project that I had started, which is Third Wave, the website, we talked a lot about microdosing, and we also specifically focused on a lot of the applicability for mushrooms or LSD or ayahuasca for innovation and creativity and problem-solving, psycho-spiritual development, these sort of things. And so, we were having this conversation and as she was saying, there are gonna be generally, we'll say as a generalization, two groups of people who, in the next five to 10 years, are going to become more and more interested in psychedelics. One of those groups of people are people that MAPS deals with and that MAPS is running the research with, people who have PTSD, people who struggle with depression, with anxiety, they're going to be drawn to psychedelics because they're simply more effective than some of the pharmaceutical substances and drugs that have been used for the past 30 to 40 years.

46:41 PA: The other group of people who are gonna become interested in this are people who wanna use them, like you were just talking about, as specific tools for cognitive enhancement, or for spirituality, or for... To live a more vibrant life in general. And obviously, there's overlap between the two. But as a generalization, I think for me, that second group is really interesting because I think that it can be potentially a very powerful group in terms of changing the cultural conversation. The fact that you live in the Bay area, you live near San Francisco, you are probably engaged in conversations in San Francisco, you've probably talked to people in the tech world, you probably talk or have spoken to other entrepreneurs. What role do you think that group of people, these people who are coming to psychedelics for creativity and for problem-solving, for psycho-spiritual development, for cognitive enhancement, what role do you see them in helping to change the cultural conversation around psychedelics?

47:45 BB: Great question, Paul, thank you. Yeah, the tech world?

47:48 PA: We could say the tech world, or yeah, we could say the startup world, or we could say entrepreneurs in general, freelancers these sorts of people.

47:57 BB: Yeah, I think anybody who fits those categories will know if they fit those categories. I think that's one sort of cultural phenomenon that's happening. The entrepreneurialism, connectivity, social change, technology, entrepreneurship, design. Yeah, for sure. So the history of psychedelics and technology and entrepreneurialism absolutely go hand-in-hand, and there's any number of histories of psychedelics that very clearly connect the growth of the counter-culture and the awareness of psychedelics, especially LSD and cannabis in the 9960s and 1970s, with the growth of the Internet, early Internet founders. All of these people were experimenting with psychedelics and were part of that movement. So, the fact that now we're seeing more entrepreneurs, engineers, talking openly about their use of psychedelics to spur their creativity and to help them in a professional context, I think it's more of a symptom that it's becoming more possible to talk openly about them. I don't know if it's something new. I think that the Internet and engineering and entrepreneur culture has always been interested in cognitive enhancers, now called nootropics.

49:09 BB: And then the increasing acceptability of LSD and other psychedelics has, I think, led people to wanna experiment more. Microdosing is a huge phenomenon that more people are starting to talk about, and I think culturally, it's important because it represents a kind of, I think, a more developed, not better, in any way, but an evolution of the use of psychedelics in that it's involving very, very small doses, and it doesn't have this... That is microdosing, using very small doses to just enhance what one is already doing, to help one be more productive or more connected. I think that's really powerful, because it's less this Timothy Leary, turn on, tune in, drop out attitude; it's more of a turn on, tune in, and stay engaged and get better at what you're doing kind of attitude. So it's not a counter-cultural ethos, this microdosing movement.

50:05 BB: I think it's a cultural ethos that is picking up steam in that way. And for those reasons, the entrepreneurial community, those who have been especially successful with startups or technology businesses are in a tremendous position to help psychedelic research become sustainable. And the fastest way forward with that right now, for example, to opening up wider uses beyond therapy for psychedelics, to help us gain legal access to, for example, LSD microdosing for entrepreneurialism or creativity, the fastest way forward for that is gonna be to make MDMA into a prescription treatment for PTSD, because that's what's gonna open up the conversation, that's what's gonna provide further funding for research.

50:49 BB: So, yeah, we've had a lot of great supporters come out of the tech space wanting to help us out, and probably in addition to financially supporting our work, we need to raise about $13 million to $14 million over the next five years to make MDMA into a prescription medicine. We've already raised about that amount, so the total amount being about 25 million. And so funding that would obviously be very, very helpful making MAPS a sustainable nonprofit in that way. But then also just speaking openly, and not being afraid to share your experience, and to be honest about your experience so that some of the stigma on psychedelic experiences continues to decrease.

51:31 PA: And I wanna go back to something you said a minute or so ago where you were talking about... You mentioned Timothy Leary, tune... Remind me, what the phrase is again?

51:41 BB: "Tune in, turn on, drop out," that's what he said.

51:44 PA: "Tune in, turn on, drop out." And it was a counter-cultural ethos, and now we're seeing this cultural ethos which ties in to some of these other aspects of, we could say, raising consciousness that people are becoming interested in: Yoga, mindfulness meditation, more and more people I know are going hiking, spending time in nature. All I think this is a trend and a move towards self-healing after living in such a sick society for so many years. But I really like how you emphasize that, where we could say this use of psychedelics, specifically microdosing is becoming more of a cultural ethos because people are realizing now that we can change the systems that we're working within, we can actually bring more consciousness into the systems that we're working within to eventually change them to be more accepting, to be more open, to be less divisive, to care more about the public in general, the community in general, rather than specific private individuals.

52:44 PA: And then we've seen this in research where psychedelics have proven, to some degree, to make people more altruistic, to make people care more about nature, to make people more loving and more accepting and more open. And so, having that as part of the cultural ethos, I think, will only help to facilitate these structural changes that we're seeing, for example, with MAPS and benefit corporations. And so I think that point is really, really interesting, that although we're seeing people who are using, for example, there have been a number of articles about microdosing related to productivity lately, and some people in the psychedelic world have kinda said, "Well, I think the point of using psychedelics is not to be more productive, necessarily." But what I think is being lost in that conversation is that it's okay if people are using it within a business sense because I think with the research that we've known and with continuous use over time, it's shown that people who are using psychedelics tend to bring more consciousness into their everyday life, and so they're pursuing... If they're pursuing some type of professional work, chances are that it's going to help with or that's going to not... What's a good way of putting it?

53:53 PA: Business isn't going to be as usual, as it has been within this destructive capitalist, extractive capitalist nature that we've seen in the past 50 or 60 years. It seems like we can still work within capitalism, but making sure that we're accounting for the human and the social costs, the community cost of capitalism, by integrating more conscious into it, and I think micro-dosing will facilitate and play a huge role in that. So I guess that's kinda where I was going with that.

54:18 BB: I completely agree with you, Paul. I think given what we know about capitalism and power of the stock markets and the way the industry works is that clearly, consciousness has a lot to do with it. Stocks are just flat lining right now. I just watch them out of curiosity, 'cause it's an interesting barometer of what's happening in our public consciousness right now, and it's because people are terrified about what's gonna happen with the election in five days. So, if economic resources at that scale, at the scale of trillions and trillions of dollars, can be affected by just how people are feeling in a given day, then imagine what could happen if we brought higher consciousness, more compassion and empathy, into where we put all of those resources. If we, as a culture and as a globe, put our resources towards things that were making people happier and healthier and more sustainable, rather than extractives and finance and retail and all of these things, I mean, the whole system could change literally overnight, and maybe that won't happen literally overnight, but all it takes is one at a time, for sure.

55:19 PA: And it does, and we're seeing this with Elon Musk and what he's doing at Tesla and with SpaceX and SolarCity. We're seeing this in all types of future ventures, and I think it's really exciting, and I think we... I keep saying this to all my friends. We live in one of the most exciting times ever, and I'm hopeful, as an optimist, that things will only continue to get better, so. I think that's a nice way to end the conversation and wrap things up. Brad, thank you so much for coming on the show, for coming on the podcast, for talking to us and telling us about your personal experience with psychedelics, the work that you're doing with MAPS. These different topics that we've discussed have been phenomenal, and it's really been a pleasure to talk to you for the past hour.

56:07 BB: Thank you, Paul, you're super, super well-informed, and thanks for all your questions, and thanks for getting out all of this great material. And I'll definitely be tuning in and listening to your next guests.

56:18 PA: Great, great, thanks so much. Now, if people wanna find out more about what MAPS is doing specific to research, or if they wanna donate to your guys' research, where can they go and what should they do?

56:33 BB: Well, thanks. Check out maps.org, that's our website, maps.org. Also, a great opportunity to get involved is coming up in April, at Psychedelic Science 2017. Paul, I hope you'll be joining us.

56:47 PA: I will, I will be there, so if... I will be there.

56:50 BB: Great.

56:50 PA: My colleague, Brian, who I'm working on Third Wave with, will also be there. So I'm trying to recruit as many people as possible.

56:57 BB: Great, well, yeah, great. So I hope that as many people as possible come out to Psychedelic Science. That's a six-day international conference and comedy banquet and cruise and workshops happening in the San Francisco Bay Area, this April. That's psychedelicscience.org.

57:13 PA: Cool. Thanks so much, Brad.

57:14 BB: Alright, thank you, Paul.

58:16 S1: Thanks for listening to The Psychedelia Podcast with Paul Austin. Want more psychedelic information? Go to our website at thethirdwave.co, and register for our email list and newsletter. Also, please consider donating to Third Wave via our Patreon page. Donations make this podcast possible. Psychedelics have the potential to transform lives. By donating, you enable us to continue to inform people about the benefits of these powerful substances.

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